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Terminated

Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S T2 Ankle Arthrd Nail lft 1818-1115S

FDA Recall Z-2884-2018 · Posted None

Recalling FirmStryker GmbH
Recall StatusTerminated
Product CodeHSB
Date Initiated2018-06-27
Date Terminated2020-04-13
Product Quantity38

Reason for Recall

Incomplete seal on the Tyvek lid may compromise the sterility of the device

Firm Action

Stryker notified consignee via UPS (with return receipt) on June 27, 2018 advising user of the problem, quarantine product and return. Complete and sign the Recall Notification Business Reply Form. Contact (201) 831-6693.

Root Cause

Packaging process control

Distribution Pattern

US distribution to KY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051590T2 ANKLE ARTHRODESIS NAILHowmedica Osteonics Corp. · 2005-07-29

Official Source

View FDA Recall →

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

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