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Terminated

Stryker brand Bioabsorbable ACL Interference Screw, 10mm X 35mm; 12mm X 35mm Part Numbers: 234-010-078; 234-010-080

FDA Recall Z-0401-05 · Posted 2005-01-15

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHWC
Date Initiated2004-12-27
Date Terminated2005-03-18
Product Quantity16 units of 078, 284 units of 080

Reason for Recall

The label on the outside of the shipping box has an incorrect description of the screw diameter.

Firm Action

Consignees have been alerted by phone calls on 12/16/2004. Formal advisory notice was sent out on 12/27/2004. All international consignees have also been alerted.

Root Cause

Other

Distribution Pattern

6 consignees (locations to be determined) received 15 units. the remaining 147 units were distributed to international divisions.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K993166STRYKER BIOABSORBABLE INTERFERENCE SCREW SYSTEMStryker Endoscopy · 2000-08-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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