PlainRecalls
FDA Devices Moderate Class II Terminated

1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 CORT SCREW CRUCI 2.0 X 30 CORT SCREW CRUCI 2.0 X 32 CORT SCREW CRUCI 2.0 X 34 CORT SCREW CRUCI 2.0 X 36 CORT SCREW CRUCI 2.0 X 38 CORT SCREW CRUCI 2.0 X 40 CORT SCREW CRUCI 2.0 X 42 CORT SCREW CRUCI 2.0 X 44 CORT

Reported: February 26, 2014 Initiated: October 11, 2013 #Z-1042-2014

Product Description

1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 CORT SCREW CRUCI 2.0 X 30 CORT SCREW CRUCI 2.0 X 32 CORT SCREW CRUCI 2.0 X 34 CORT SCREW CRUCI 2.0 X 36 CORT SCREW CRUCI 2.0 X 38 CORT SCREW CRUCI 2.0 X 40 CORT SCREW CRUCI 2.0 X 42 CORT SCREW CRUCI 2.0 X 44 CORT SCREW CRUCI 2.0 X 46 CORT SCREW CRUCI 2.0 X 48 CORT SCREW CRUCI 2.0 X 50 CORT SCREW CRUCI 2.7MM CORT. SCREW 6MM, ST 2.7MM CORT. SCREW 7MM, ST 2.7MM CORT. SCREW 8MM, ST 2.7MM CORT. SCREW 9MM, ST 2.7MM CORT. SCREW 10MM, S 2.7MM CORT. SCREW 12MM, S 2.7MM CORT. SCREW 14MM, S 2.7MM CORT. SCREW 16MM, S 2.7MM CORT. SCREW 18MM, S 2.7MM CORT. SCREW 20MM, S 2.7MM CORT. SCREW 22MM, S 2.7MM CORT. SCREW 24MM, S 2.7MM CORT. SCREW 26MM, S 2.7MM CORT. SCREW 28MM, S 2.7MM CORT. SCREW 30MM, S 2.7MM CORT. SCREW 32MM, S 2.7MM CORT. SCREW 34MM, S 2.7MM CORT. SCREW 36MM, S 2.7MM CORT. SCREW 38MM, S 2.7MM CORT. SCREW 40MM, S 2.7MM CORT. SCREW 42MM, S 2.7MM CORT. SCREW 44MM, S 2.7MM CORT. SCREW 45MM, S 2.7MM CORT. SCREW 46MM, S 2.7MM CORT. SCREW 48MM, S 2.7MM CORT. SCREW 50MM, S 2.7X52 CORT SCREW/SELFTAP 2.7X54 CORT SCREW/SELFTAP 2.7X55 CORT SCREW/SELFTAP 2.7X56 CORT SCREW/SELFTAP 2.7X58 CORT SCREW/SELFTAP 2.7X60 CORT SCREW/SELFTAP 2.7X65 CORT SCREW/SELFTAP 2.7X70 CORT SCREW/SELFTAP 3.5MM CORT. SCREW 10MM LN 3.5MM CORT. SCREW 12MM LN 3.5X14 CORT SCREW 3.5MM CORT. SCREW 14MM LN 3.5X16 CORT SCREW 3.5MM CORT. SCREW 16MM LN 3.5 X 16 SHAFT SCREW 3.5X18 CORT SCREW 3.5MM CORT. SCREW 18MM LN 3.5 X 18 SHAFT SCREW 3.5MM CORT. SCREW 20MM LN 3.5 X 20 SHAFT SCREW 3.5MM CORT. SCREW 22MM LN 3.5 X 22 SHAFT SCREW 3.5MM CORT. SCREW 24MM LN 3.5 X 24 SHAFT SCREW 3.5MM CORT. SCREW 26MM LN 3.5 X 26 SHAFT SCREW 3.5MM CORT. SCREW 28MM LN 3.5 X 28 SHAFT SCREW 3.5MM CORT. SCREW 30MM LN 3.5 X 30 SHAFT SCREW 3.5MM CORT. SCREW 32MM LN 3.5 X 32 SHAFT SCREW 3.5MM CORT. SCREW 34MM LN 3.5 X 34 SHAFT SCREW 3.5MM CORT. SCREW 36MM LN 3.5 X 36 SHAFT SCREW 3.5MM CORT. SCREW 38MM LN 3.5 X 38 SHAFT SCREW 3.5MM CORT. SCREW 40MM LN 3.5 X 40 SHAFT SCREW 3.5MM CORT. SCREW 45MM LN 3.5MM CORT. SCREW 50MM LN 3.5 X 50 SHAFT SCREW 3.5MM CORT. SCREW 55MM LN 3.5MM CORT. SCREW 60MM LN 3.5MM CORT. SCREW 65MM LN 3.5MM CORT. SCREW 70MM LN 3.5MM CORT. SCREW 75MM LN 3.5MM CORT. SCREW 80MM LN 3.5X85 CORT SCREW 3.5X90 CORT SCREW 3.5X95 CORT SCREW 3.5X100 CORT SCREW 3.5X105 CORT SCREW 3.5X110 CORT SCREW 3.5X115 CORT SCREW 3.5X120 CORT SCREW 3.5X125 CORT SCREW 3.5X130 CORT SCREW 3.5X135 CORT SCREW 3.5X140 CORT SCREW 3.5X145 CORT SCREW 3.5X150 CORT SCREW 4.0 X 10 CANCELL. SCREW 4.0 X 10 PART THD CANC SC 4.0 X 12 CANCELL. SCREW 4.0 X 12 PART THD CANC SC 4.0 X 14 CANCELL. SCREW 4.0 X 14 PART THD CANC SC 4.0 X 16 CANCELL. SCREW 4.0 X 16 PART THD CANC SC 4.0 X 18 CANCELL. SCREW 4.0 X 18 PART THD CANC SC 4.0 X 20 CANCELL. SCREW 4.0 X 20 PART THD CANC SC 4.0 X 22 CANCELL. SCREW 4.0 X 22 PART THD CANC SC 4.0 X 24 CANCELL. SCREW 4.0 X 24 PART THD CANC SC 4.0 X 26 CANCELL. SCREW 4.0 X 26 PART THD CANC SC 4.0 X 28 CANCELL. SCREW 4.0 X 28 PART THD CANC SC 4.0 X 30 CANCELL. SCREW 4.0 X 30 PART THD CANC SC 4.0 X 32 CANCELL. SCREW 4.0 X 34 CANCELL. SCREW 4.0 X 35 PART THD CANC SC 4.0 X 36 CANCELL. SCREW 4.0 X 40 CANCELL. SCREW 4.0 X 40 PART THD CANC SC 4.0 X 45 CANCELL. SCREW 4.0 X 45 PART THD CANC SC 4.0 X 50 CANCELL. SCREW 4.0 X 50 PART THD CANC SC 4.0 X 55 CANCELL. SCREW 4.0 X 55 PART THD CANC SC 4.0 X 60 CANCELL. SCREW 4.0 X 60 PART THD CANC SC 4.0 X 65 CANCELL. SCREW 4.0

Reason for Recall

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
7,044,680 total
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled? ▼
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 CORT SCREW CRUCI 2.0 X 30 CORT SCREW CRUCI 2.0 X 32 CORT SCREW CRUCI 2.0 X 34 CORT SCREW CRUCI 2.0 X 36 CORT SCREW CRUCI 2.0 X 38 CORT SCREW CRUCI 2.0 X 40 CORT SCREW CRUCI 2.0 X 42 CORT SCREW CRUCI 2.0 X 44 CORT SCREW CRUCI 2.0 X 46 CORT SCREW CRUCI 2.0 X 48 CORT SCREW CRUCI 2.0 X 50 CORT SCREW CRUCI 2.7MM CORT. SCREW 6MM, ST 2.7MM CORT. SCREW 7MM, ST 2.7MM CORT. SCREW 8MM, ST 2.7MM CORT. SCREW 9MM, ST 2.7MM CORT. SCREW 10MM, S 2.7MM CORT. SCREW 12MM, S 2.7MM CORT. SCREW 14MM, S 2.7MM CORT. SCREW 16MM, S 2.7MM CORT. SCREW 18MM, S 2.7MM CORT. SCREW 20MM, S 2.7MM CORT. SCREW 22MM, S 2.7MM CORT. SCREW 24MM, S 2.7MM CORT. SCREW 26MM, S 2.7MM CORT. SCREW 28MM, S 2.7MM CORT. SCREW 30MM, S 2.7MM CORT. SCREW 32MM, S 2.7MM CORT. SCREW 34MM, S 2.7MM CORT. SCREW 36MM, S 2.7MM CORT. SCREW 38MM, S 2.7MM CORT. SCREW 40MM, S 2.7MM CORT. SCREW 42MM, S 2.7MM CORT. SCREW 44MM, S 2.7MM CORT. SCREW 45MM, S 2.7MM CORT. SCREW 46MM, S 2.7MM CORT. SCREW 48MM, S 2.7MM CORT. SCREW 50MM, S 2.7X52 CORT SCREW/SELFTAP 2.7X54 CORT SCREW/SELFTAP 2.7X55 CORT SCREW/SELFTAP 2.7X56 CORT SCREW/SELFTAP 2.7X58 CORT SCREW/SELFTAP 2.7X60 CORT SCREW/SELFTAP 2.7X65 CORT SCREW/SELFTAP 2.7X70 CORT SCREW/SELFTAP 3.5MM CORT. SCREW 10MM LN 3.5MM CORT. SCREW 12MM LN 3.5X14 CORT SCREW 3.5MM CORT. SCREW 14MM LN 3.5X16 CORT SCREW 3.5MM CORT. SCREW 16MM LN 3.5 X 16 SHAFT SCREW 3.5X18 CORT SCREW 3.5MM CORT. SCREW 18MM LN 3.5 X 18 SHAFT SCREW 3.5MM CORT. SCREW 20MM LN 3.5 X 20 SHAFT SCREW 3.5MM CORT. SCREW 22MM LN 3.5 X 22 SHAFT SCREW 3.5MM CORT. SCREW 24MM LN 3.5 X 24 SHAFT SCREW 3.5MM CORT. SCREW 26MM LN 3.5 X 26 SHAFT SCREW 3.5MM CORT. SCREW 28MM LN 3.5 X 28 SHAFT SCREW 3.5MM CORT. SCREW 30MM LN 3.5 X 30 SHAFT SCREW 3.5MM CORT. SCREW 32MM LN 3.5 X 32 SHAFT SCREW 3.5MM CORT. SCREW 34MM LN 3.5 X 34 SHAFT SCREW 3.5MM CORT. SCREW 36MM LN 3.5 X 36 SHAFT SCREW 3.5MM CORT. SCREW 38MM LN 3.5 X 38 SHAFT SCREW 3.5MM CORT. SCREW 40MM LN 3.5 X 40 SHAFT SCREW 3.5MM CORT. SCREW 45MM LN 3.5MM CORT. SCREW 50MM LN 3.5 X 50 SHAFT SCREW 3.5MM CORT. SCREW 55MM LN 3.5MM CORT. SCREW 60MM LN 3.5MM CORT. SCREW 65MM LN 3.5MM CORT. SCREW 70MM LN 3.5MM CORT. SCREW 75MM LN 3.5MM CORT. SCREW 80MM LN 3.5X85 CORT SCREW 3.5X90 CORT SCREW 3.5X95 CORT SCREW 3.5X100 CORT SCREW 3.5X105 CORT SCREW 3.5X110 CORT SCREW 3.5X115 CORT SCREW 3.5X120 CORT SCREW 3.5X125 CORT SCREW 3.5X130 CORT SCREW 3.5X135 CORT SCREW 3.5X140 CORT SCREW 3.5X145 CORT SCREW 3.5X150 CORT SCREW 4.0 X 10 CANCELL. SCREW 4.0 X 10 PART THD CANC SC 4.0 X 12 CANCELL. SCREW 4.0 X 12 PART THD CANC SC 4.0 X 14 CANCELL. SCREW 4.0 X 14 PART THD CANC SC 4.0 X 16 CANCELL. SCREW 4.0 X 16 PART THD CANC SC 4.0 X 18 CANCELL. SCREW 4.0 X 18 PART THD CANC SC 4.0 X 20 CANCELL. SCREW 4.0 X 20 PART THD CANC SC 4.0 X 22 CANCELL. SCREW 4.0 X 22 PART THD CANC SC 4.0 X 24 CANCELL. SCREW 4.0 X 24 PART THD CANC SC 4.0 X 26 CANCELL. SCREW 4.0 X 26 PART THD CANC SC 4.0 X 28 CANCELL. SCREW 4.0 X 28 PART THD CANC SC 4.0 X 30 CANCELL. SCREW 4.0 X 30 PART THD CANC SC 4.0 X 32 CANCELL. SCREW 4.0 X 34 CANCELL. SCREW 4.0 X 35 PART THD CANC SC 4.0 X 36 CANCELL. SCREW 4.0 X 40 CANCELL. SCREW 4.0 X 40 PART THD CANC SC 4.0 X 45 CANCELL. SCREW 4.0 X 45 PART THD CANC SC 4.0 X 50 CANCELL. SCREW 4.0 X 50 PART THD CANC SC 4.0 X 55 CANCELL. SCREW 4.0 X 55 PART THD CANC SC 4.0 X 60 CANCELL. SCREW 4.0 X 60 PART THD CANC SC 4.0 X 65 CANCELL. SCREW 4.0. Recalled by Zimmer, Inc.. Units affected: 7,044,680 total.
Why was this product recalled? ▼
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-1042-2014.

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